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Lupin Ltd has received approval from the U.S. FDA for its ANDA for Glycopyrrolate Injection USP, a generic equivalent of Robinul® Injection, 0.2 mg/mL of Hikma Pharmaceuticals USA Inc. This is the first approval from its Nagpur injectable facility.
Lupin Limited today announced that it has received approval from the United States Food and Drug Administration (U.S.FDA) for its abbreviated new drug application for Glycopyrrolate Injection USP, via an exchange filing.
Leuprolide Acetate for injection is indicated for the treatment used to treat the symptoms associated with advanced prostate cancer by way of Palliative treatment of advanced prostatic cancer.
Uniindia: Hyderabad, June 7 (UNI) Aurobindo Pharma Ltd on Tuesday announced that its wholly owned subsidiary, Eugia Pharma Specialties Ltd, has received a final approval from the US Food and Drug Administration (USFDA) to manufacture and market Leuprolide Acetate Injection, 14 mg/2.8 mL MDV (Kit).
Limitations and Safety Concerns of the Pfizer Vaccine The FDA's Advisory Committee on Immunization Practices (ACIP) panelists met Dec. 11 and recommended approval of the vaccine for those age 16 and older. The panel said clinicians need more guidance on whether to use the vaccine on pregnant or breastfeeding women, the immunocompromised, those who have a history of allergies and those under age 16. The FDA-issued healthcare provider information sheet on the vaccine said there is not enough data to recommend vaccinating those women or the immunocompromised, and also advises against giving ...